Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder
MOONSTONE
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD
2 other identifiers
interventional
600
1 country
37
Brief Summary
This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
Started Apr 2006
Shorter than P25 for phase_3 major-depressive-disorder
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 1, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMarch 25, 2009
March 1, 2009
May 1, 2006
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Secondary Outcomes (2)
Change from randomization to each assessment in the MADRS total score
MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6
Interventions
Eligibility Criteria
You may qualify if:
- Patient has a documented clinical diagnosis of Major Depressive Disorder.
- Be able to understand and comply with the requirements of the study.
- Able to understand and provide written informed consent
You may not qualify if:
- Patients (female) must not be pregnant or lactating
- Current or past diagnosis of stroke or transient ischemic attack (TIA).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (37)
Research Site
Little Rock, Arkansas, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Oceanside, California, United States
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Santa Ana, California, United States
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Denver, Colorado, United States
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Norwich, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Smyrna, Georgia, United States
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Eagle, Idaho, United States
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Oak Brook, Illinois, United States
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Wichita, Kansas, United States
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Shreveport, Louisiana, United States
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Farmington Hills, Michigan, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Cherry Hill, New Jersey, United States
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Clementon, New Jersey, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Staten Island, New York, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Norristown, Pennsylvania, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Bellevue, Washington, United States
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Seattle, Washington, United States
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Charleston, West Virginia, United States
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Brown Deer, Wisconsin, United States
Related Publications (9)
McIntyre RS, Gorwood P, Thase ME, Liss C, Desai D, Chen J, Bauer M. Early Symptom Improvement as a Predictor of Response to Extended Release Quetiapine in Major Depressive Disorder. J Clin Psychopharmacol. 2015 Dec;35(6):706-10. doi: 10.1097/JCP.0000000000000416.
PMID: 26474010DERIVEDWeisler R, Montgomery SA, Earley WR, Szamosi J, Eriksson H. Extended release quetiapine fumarate in patients with major depressive disorder: suicidality data from acute and maintenance studies. J Clin Psychiatry. 2014 May;75(5):520-7. doi: 10.4088/JCP.13m08624.
PMID: 24816198DERIVEDWeisler R, McIntyre RS. The role of extended-release quetiapine fumarate monotherapy in the treatment of patients with major depressive disorder. Expert Rev Neurother. 2013 Nov;13(11):1161-82. doi: 10.1586/14737175.2013.846520.
PMID: 24175720DERIVEDClayton AH, Locklear JC, Svedsater H, McIntyre RS. Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate. CNS Spectr. 2014 Apr;19(2):182-96. doi: 10.1017/S1092852913000631. Epub 2013 Sep 25.
PMID: 24067192DERIVEDTrivedi MH, Bandelow B, Demyttenaere K, Papakostas GI, Szamosi J, Earley W, Eriksson H. Evaluation of the effects of extended release quetiapine fumarate monotherapy on sleep disturbance in patients with major depressive disorder: a pooled analysis of four randomized acute studies. Int J Neuropsychopharmacol. 2013 Sep;16(8):1733-44. doi: 10.1017/S146114571300028X. Epub 2013 May 14.
PMID: 23673347DERIVEDVieta E, Bauer M, Montgomery S, McIntyre RS, Szamosi J, Earley WR, Eriksson H. Pooled analysis of sustained response rates for extended release quetiapine fumarate as monotherapy or adjunct to antidepressant therapy in patients with major depressive disorder. J Affect Disord. 2013 Sep 5;150(2):639-43. doi: 10.1016/j.jad.2013.01.052. Epub 2013 Mar 14.
PMID: 23497790DERIVEDThase ME, Montgomery S, Papakostas GI, Bauer M, Trivedi MH, Svedsater H, Locklear JC, Gustafsson U, Datto C, Eriksson H. Quetiapine XR monotherapy in major depressive disorder: a pooled analysis to assess the influence of baseline severity on efficacy. Int Clin Psychopharmacol. 2013 May;28(3):113-20. doi: 10.1097/YIC.0b013e32835fb971.
PMID: 23485955DERIVEDWeisler RH, Montgomery SA, Earley WR, Szamosi J, Lazarus A. Efficacy of extended release quetiapine fumarate monotherapy in patients with major depressive disorder: a pooled analysis of two 6-week, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2012 Jan;27(1):27-39. doi: 10.1097/YIC.0b013e32834d6f91.
PMID: 22027845DERIVEDWeisler R, Joyce M, McGill L, Lazarus A, Szamosi J, Eriksson H; Moonstone Study Group. Extended release quetiapine fumarate monotherapy for major depressive disorder: results of a double-blind, randomized, placebo-controlled study. CNS Spectr. 2009 Jun;14(6):299-313. doi: 10.1017/s1092852900020307.
PMID: 19668121DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Art Lazarus, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 1, 2006
First Posted
May 3, 2006
Study Start
April 1, 2006
Study Completion
May 1, 2007
Last Updated
March 25, 2009
Record last verified: 2009-03